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Can a direct blood test spot infections faster than cultures?

NCT ID NCT07859852

Diagnosis Sponsor: Deepull Diagnostics S.L. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 06, 2026 · Last updated Oct 09, 2026 · Updated 3 times

Summary

Researchers are evaluating a new molecular test called the UllCORE BSI Test, which aims to detect bacteria, fungi, and antibiotic resistance markers directly from whole blood in people with suspected bloodstream infection or sepsis. The study enrolls about 1,500 participants of any age who are having standard blood cultures drawn. Blood samples are tested with the new test, and results are compared with standard microbiology to see how well the test agrees. The test results are not used to guide treatment, so participation does not change the care participants receive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an investigational molecular diagnostic test that detects microorganisms and antibiotic resistance markers directly from whole blood
What this could lead to
If it works, the test could help doctors identify bloodstream infections and antibiotic resistance faster than standard blood cultures, which may guide treatment sooner.
What could go wrong
The test is still investigational and its results will not guide patient care in this study. It may miss infections that standard cultures detect, or it may flag organisms that are not actually causing illness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of patients with suspected bloodstream infection (BSI) or sepsis who are undergoing standard-of-care blood culture testing. Participants will be recruited from Emergency Departments and Intensive Care Units. Eligible patients will be identified based on clinical signs and symptoms consistent with suspected BSI or sepsis, such as fever, elevated inflammatory markers, hypotension, or other clinical findings prompting blood culture collection. Participants meeting the eligibility criteria will be enrolled prospectively and consecutively, without preference for specific demographic or clinical characteristics.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Any age (where the remaining criteria can be safely fulfilled) * Ability to provide consent/assent in accordance with Institutional Review Board (IRB)/Ethics Committee (EC) determinations * The patient is presenting with signs and symptoms of suspected bloodstream infection (BSI) or fulfils the criteria for the hospital sepsis protocol. Planned blood culture collection and laboratory analysis as per standard of care (SOC). • Patient is able and an appropriate candidate to be able to collect 2 K2 ethylenediaminetetraacetic acid (EDTA) tubes of whole blood. Exclusion Criteria: * Unable to collect UllCORE BSI Test samples from the same venipuncture as blood culture (BC) samples * Patient was previously enrolled in the study

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis Fungemia infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bacteremia Blood stream infection Blood stream infections Fungemia Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Careggi

    NOT_YET_RECRUITING

    Florence, 50134, Italy

  • Baylor Scott & White Health Medical Center-Temple

    NOT_YET_RECRUITING

    Temple, Texas, 76508, United States

  • Beth Israel Deaconess Medical Center

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • CHU de Limoges - Hôpital Dupuytren

    NOT_YET_RECRUITING

    Limoges, 87000, France

  • Charité - Campus Benjamin Franklin

    NOT_YET_RECRUITING

    Berlin-Zehlendorf, 12203, Germany

  • Geisinger Health

    NOT_YET_RECRUITING

    Danville, Pennsylvania, 17822, United States

  • Henry Ford Health

    NOT_YET_RECRUITING

    Novi, Michigan, 48374, United States

  • Hospital Clínic de Barcelona

    NOT_YET_RECRUITING

    Barcelona, 08036, Spain

  • Hospital Germans Trias I Pujol

    NOT_YET_RECRUITING

    Badalona, Spain

  • Hospital Universitari Vall d'Hebron - VHIO

    NOT_YET_RECRUITING

    Barcelona, 08035, Spain

  • Hôpital de la Croix-Rousse - HCL

    NOT_YET_RECRUITING

    Lyon, 69004, France

  • Ospedale di Perugia Santa Maria della Misericordia

    NOT_YET_RECRUITING

    Perugia, 06129, Italy

  • Tampa General Hospital

    NOT_YET_RECRUITING

    Tampa, Florida, 33606, United States

  • The Johns Hopkins Hospital

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

  • Universitaetsklinikum Jena

    NOT_YET_RECRUITING

    Jena, 07443, Germany

  • Universitaetsklinikum Leipzig

    NOT_YET_RECRUITING

    Leipzig, 04103, Germany

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California at Irvine Medical Center

    NOT_YET_RECRUITING

    Orange, California, 92868, United States

  • Vanderbilt health

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

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